Fulfillment of Postmarketing Requirements to the FDA for Therapies Granted Oncology Indications Between 2011 and 2016

Author:

Zettler Marjorie1,Nabhan Chadi1

Affiliation:

1. Cardinal Health Specialty Solutions, Cardinal Health, Dublin, Ohio

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Reference3 articles.

1. The trade-off between speed and safety in drug approvals.;Jena;JAMA Oncol,2017

2. The fate of FDA postapproval studies.;Woloshin;N Engl J Med,2017

3. US Government Accountability Office. DRUG SAFETY: FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement (GAO-16-192: Published December 15, 2015. Publicly released January 14, 2016.) https://www.gao.gov/products/GAO-16-192. Accessed February 27, 2018.

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